Lotte Biologics USA, LLCJune 5, 2019

FDA 483 - Lotte Biologics USA, LLC - June 05, 2019

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Record Details

An FDA inspection of Bristol-Myers Squibb Co., Pharmaceutical Research Institute in East Syracuse, NY, from May 28 to June 5, 2019, revealed a significant failure in their quality control processes. The firm did not thoroughly review unexplained discrepancies and out-of-specification (OOS) results. Specifically, OOS results were invalidated, and passing retest results were reported without identifying scientifically sound and justifiable root causes.

Company: Lotte Biologics USA, LLC
Inspection Date: June 5, 2019
Product Type: Biologics
Office: New Jersey District Office
Person: Tamil Arasu (Consumer Safety Officer - Dedicated Foreign Drug Cadre)

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ID · a3d0045b-bbd4-4a87-b520-06cb96ab02d5